NCT01209260

Brief Summary

This is a randomized controlled trial examining whether a mechanical needle versus a needle that uses radiofrequency energy is better at puncturing through a thin wall in the heart (called "transseptal puncture") as measured by procedure time, during an electrical procedure/study of the heart .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2010

Completed
18 days until next milestone

First Posted

Study publicly available on registry

September 27, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

January 28, 2014

Completed
Last Updated

February 28, 2014

Status Verified

January 1, 2014

Enrollment Period

2 years

First QC Date

September 9, 2010

Results QC Date

December 5, 2013

Last Update Submit

January 28, 2014

Conditions

Heart Diseases

Keywords

Transseptal PunctureRadiofrequency EnergyLeft Atrium AccessLeft Atrial CatheterizationAblationTransseptal CatheterizationElectrocauteryCatheter AblationAtrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • Transseptal Access Procedure Time

    Total amount of procedure time, from the beginning of the transseptal procedure until left atrium (LA) access is obtained in each patient. Participants for whom puncture failed crossed over to the other Intervention. Analysis performed on an intention-to-treat basis.

    Day of procedure

Secondary Outcomes (3)

  • Number of Participants With Adverse Events as a Measure of Safety

    During or immediately after procedure, up to 1 day after procedure. On average, up to 1 day after the procedure.

  • Performance of the Assigned Needle Type

    at time of procedure

  • Plastic Dilator Shavings

    immediately prior to procedure

Study Arms (2)

Radiofrequency energy needle

EXPERIMENTAL

Radiofrequency energy needle for transseptal access

Device: Radiofrequency energy needle

Mechanical needle

ACTIVE COMPARATOR

Mechanical (Brockenbrough) needle for transseptal access

Device: Mechanical Needle

Interventions

Radiofrequency energy needleDEVICE

Radiofrequency energy needle for transseptal access

Also known as: Baylis Medical Inc. transseptal needle, NRG RF transseptal needle
Radiofrequency energy needle
Mechanical NeedleDEVICE

Mechanical needle for transseptal access

Also known as: Brockenbrough Needle
Mechanical needle

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing radiofrequency ablation within the left atrium through a transseptal approach
  • Patients greater than 18 years of age

You may not qualify if:

  • Patients unable to grant informed, written consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (10)

  • ROSS J Jr, BRAUNWALD E, MORROW AG. Transseptal left atrial puncture; new technique for the measurement of left atrial pressure in man. Am J Cardiol. 1959 May;3(5):653-5. doi: 10.1016/0002-9149(59)90347-9. No abstract available.

    PMID: 13649591BACKGROUND

  • B-Lundqvist C, Olsson SB, Varnauskas E. Transseptal left heart catheterization: a review of 278 studies. Clin Cardiol. 1986 Jan;9(1):21-6. doi: 10.1002/clc.4960090105.

    PMID: 3943231BACKGROUND

  • Roelke M, Smith AJ, Palacios IF. The technique and safety of transseptal left heart catheterization: the Massachusetts General Hospital experience with 1,279 procedures. Cathet Cardiovasc Diagn. 1994 Aug;32(4):332-9. doi: 10.1002/ccd.1810320409.

    PMID: 7987913BACKGROUND

  • De Ponti R, Cappato R, Curnis A, Della Bella P, Padeletti L, Raviele A, Santini M, Salerno-Uriarte JA. Trans-septal catheterization in the electrophysiology laboratory: data from a multicenter survey spanning 12 years. J Am Coll Cardiol. 2006 Mar 7;47(5):1037-42. doi: 10.1016/j.jacc.2005.10.046. Epub 2006 Feb 9.

    PMID: 16516090BACKGROUND

  • Bidart C, Vaseghi M, Cesario DA, Mahajan A, Fujimura O, Boyle NG, Shivkumar K. Radiofrequency current delivery via transseptal needle to facilitate septal puncture. Heart Rhythm. 2007 Dec;4(12):1573-6. doi: 10.1016/j.hrthm.2007.07.008. Epub 2007 Jul 14. No abstract available.

    PMID: 17997362BACKGROUND

  • Justino H, Benson LN, Nykanen DG. Transcatheter creation of an atrial septal defect using radiofrequency perforation. Catheter Cardiovasc Interv. 2001 Sep;54(1):83-7. doi: 10.1002/ccd.1244.

    PMID: 11553955BACKGROUND

  • Smelley MP, Shah DP, Weisberg I, Kim SS, Lin AC, Beshai JF, Burke MC, Knight BP. Initial experience using a radiofrequency powered transseptal needle. J Cardiovasc Electrophysiol. 2010 Apr;21(4):423-7. doi: 10.1111/j.1540-8167.2009.01656.x. Epub 2009 Nov 17.

    PMID: 19925604BACKGROUND

  • Sakata Y, Feldman T. Transcatheter creation of atrial septal perforation using a radiofrequency transseptal system: novel approach as an alternative to transseptal needle puncture. Catheter Cardiovasc Interv. 2005 Mar;64(3):327-32. doi: 10.1002/ccd.20284.

    PMID: 15736263BACKGROUND

  • Crystal MA, Mirza MA, Benson LN. A radiofrequency transseptal needle: initial animal studies. Catheter Cardiovasc Interv. 2010 Nov 1;76(5):769-73. doi: 10.1002/ccd.22600.

    PMID: 20506170BACKGROUND

  • Hsu JC, Badhwar N, Gerstenfeld EP, Lee RJ, Mandyam MC, Dewland TA, Imburgia KE, Hoffmayer KS, Vedantham V, Lee BK, Tseng ZH, Scheinman MM, Olgin JE, Marcus GM. Randomized trial of conventional transseptal needle versus radiofrequency energy needle puncture for left atrial access (the TRAVERSE-LA study). J Am Heart Assoc. 2013 Sep 17;2(5):e000428. doi: 10.1161/JAHA.113.000428.

    PMID: 24045120DERIVED

MeSH Terms

Conditions

Heart DiseasesAtrial Fibrillation

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesArrhythmias, CardiacPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Jonathan Hsu, MD, MAS
Organization
University of California San Diego
jonathan.hsu@ucsd.edu
415-476-5706

Study Officials

  • Gregory Marcus, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

  • Jonathan Hsu, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2010

First Posted

September 27, 2010

Study Start

November 1, 2010

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

February 28, 2014

Results First Posted

January 28, 2014

Record last verified: 2014-01

Locations

US(1)